WO2011097374A1 - Dispositif de biopsie endoscopique souple guidé par ultrasons - Google Patents

Dispositif de biopsie endoscopique souple guidé par ultrasons Download PDF

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Publication number
WO2011097374A1
WO2011097374A1 PCT/US2011/023598 US2011023598W WO2011097374A1 WO 2011097374 A1 WO2011097374 A1 WO 2011097374A1 US 2011023598 W US2011023598 W US 2011023598W WO 2011097374 A1 WO2011097374 A1 WO 2011097374A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
distal portion
distal
lumen
bending stiffness
Prior art date
Application number
PCT/US2011/023598
Other languages
English (en)
Inventor
Shawn Ryan
Original Assignee
Boston Scientific Scimed, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Boston Scientific Scimed, Inc. filed Critical Boston Scientific Scimed, Inc.
Priority to JP2012552082A priority Critical patent/JP2013518677A/ja
Priority to CA2786908A priority patent/CA2786908A1/fr
Priority to EP11703351A priority patent/EP2531111A1/fr
Publication of WO2011097374A1 publication Critical patent/WO2011097374A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A61B10/0283—Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/04—Endoscopic instruments
    • A61B2010/045—Needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/0841—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating instruments

Definitions

  • Needle biopsy procedures are common for the diagnosis and the staging of disease.
  • EUS-FNA endoscopic ultrasound-guided fine needle aspiration
  • the needle is advanced under ultrasound guidance so that the physician is able to visualize a position of the needle in relation to the target tissue.
  • EUS-FNA ensures that the correct tissue is sampled while minimizing risk to the patient.
  • EUS-FNA is a highly sensitive and specific procedure, it is often difficult to acquire a suitable sample under certain clinical situations.
  • needles designed for procedures requiring navigation along tortuous paths to target sites from which it is desired to collect tissue are generally small in diameter and formed of flexible materials.
  • the most common current EUS-FNA needle device is a 22ga stainless steel needle having an outer diameter of 0.028" and an inner diameter of approximately 0.020" with an elastic modulus of 28,000,000 psi.
  • the present invention is directed to a needle for insertion into a living body along a tortuous path comprising an elongate body extending between a proximal end which, during use, remains external to the body and a distal end which, when in an operative configuration, is positioned adjacent to a target structure within the body, a distal portion of the needle including a lumen extending therethrough to a tissue receiving opening at the distal end, the lumen having an inner diameter of at least 0.035 inches and a bending stiffness no greater than 0.08 Nm 2
  • FIG. 1 shows a side view a distal portion of a device according to an exemplary embodiment of the present invention.
  • Fig. 2 shows a cross-sectional view of the device of Fig. 1, along line A-A.
  • the present invention may be further understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals.
  • the present invention relates to endoscopic devices and, in particular, relates to an improved endoscopic device having a larger inner diameter while maintaining a flexibility sufficient to permit navigation of the device along a tortuous path.
  • the most common EUS-FNA device is a 22ga needle having a lumen with an inner diameter of approximately 0.020".
  • the 22ga needle is most commonly used because of its low bending stiffness, which allows the 22ga needle to traverse the winding paths of body lumens.
  • a lumen of at least 0.035" (corresponding to a 19ga needle) would be preferably, such needles are not utilized because the needles having such larger inner diameters generally show a bending stiffness that prevents the needle from traversing the winding paths of natural body lumens in the manner of the 22ga needles.
  • Exemplary embodiments of the present invention describe an endoscopic biopsy device formed of a material permitting the device to include a lumen having an inner diameter of at least 0.035" and a bending stiffness of no greater than 0.08 Nm .
  • Conventional EUS-FNA materials and construction do not permit such a low bending stiffness value for needles including an inner diameter of at least 0.035".
  • the devices according to the invention are capable of passing through the body along tortuous paths (e.g., within natural body lumens) while maintaining a larger inner diameter for collecting tissue samples and/or transferring fluids.
  • a device 100 comprises a longitudinal element 102 extending from a proximal end (not shown) to a distal end 104 with a lumen 106 extending therethrough.
  • the distal end 104 may include a tapered tip for piercing tissue masses or surfaces.
  • a tissue sample may be collected within the lumen 106.
  • a syringe or other medical device may be coupled to the proximal end to facilitate the transfer of fluids through the lumen 106 to/from a target area via the distal end 104.
  • a distal portion 108 of the longitudinal element 102 is formed of a material that permits the lumen 106 to include an inner diameter (ID) of at least 0.035" (e.g., an inner diameter of a typical 19ga needle) while maintaining a bending stiffness less than or equal to 0.08 Nm 2 such that the device 100 is navigable through a tortuous path in a manner that approaches conventional 22ga needles.
  • ID inner diameter
  • a proximal portion of the device 100 extending from the distal portion 108 to a proximal end of the device 100 may be formed as a solid tube or coil of another material such as stainless steel to maintain the desired axial strength and bending stiffness of the device 100.
  • the proximal portion is formed as a coil
  • the coil will be sealed with a flexible membrane or other lining to transmit fluid/suction along an entire length of the lumen 106.
  • the lumen 106 extends to a tissue receiving opening 105 in the distal end 104 which may be formed via an angled cut of the distal end 104 of the needle 100 or as a lateral opening in a wall of the needle 100.
  • bending stiffness is a key factor in determining the degree of bending a device is suited for in traversing tortuous paths.
  • the bending stiffness is determined by the product of an elastic modulus of the material, E, and an area moment of inertia, I.
  • the elastic modulus E is defined as the ratio of stress to strain and, for many materials, shows a range through which E is substantially constant changing at a yield point to a non-linear relationship. Strains in this non-linear range (i.e., beyond the yield point) cause plastic deformation of the material.
  • bending stiffness may be reduced by reducing a wall thickness W (i.e., a difference between the outer diameter OD and the inner diameter ID).
  • reducing the wall thickness may compromise the structural integrity of the device 100.
  • improperly reduced wall thickness may lead to structural failures resulting from small defects in the device 100 and/or compressive stresses (e.g., "kinks") when the device 100 is passed along a curved path.
  • the distal portion 108 will include an outer diameter OD that does not exceed 0.052", and more preferably does not exceed 0.047", such that the wall thickness W is between 0.001 " and 0.008".
  • the wall thickness W will may depend on several factors including, for example, defect size in the raw material, path tortuosity, axial loading, etc.
  • Nitinol shows a value of E which is lower so that, for a needle of the same cross-sectional area, the bending stiffness will be lower while the yield point is not reached until levels of stress greater than those to which the needles are to be subjected during normal use so that a 19 gauge Nitinol needle shows the required bending stiffness without the plastic deformation associated with needle failure.
  • the distal portion 108 of the device 100 is formed of a material having an elastic modulus E that ranges between 7,000,000 to 10,000,000 psi.
  • the device 100 may be formed of Nitinol.
  • materials such as copper, titanium and aluminum may also be used.
  • copper or brass needles need to be coated with a biocompatible material for use within the body.
  • the bending stiffness of Titanium is greater than that of Nitinol making it slightly less suitable for this application.
  • a device 100 formed of Nitinol allows the inner diameter of the lumen to be made at least 0.035" while maintaining a bending stiffness substantially lower, up to 75% lower, than currently used materials such as stainless steel.
  • the Nitinol is able to reduce the bending stiffness, enhancing torquability, while also maintaining the preferred wall thickness.
  • Nitinol also provides higher compressive stiffness than other materials such as plastics such that the compressive stiffness is sufficient to enable the distal end 104 to penetrate even fibrous lesions and maintains the lumen 106 in a sealed configuration such that fluid may be transferred through the lumen 106 to the target area.
  • Nitinol also possesses other unique mechanical properties, which may provide further benefit to the device 100. For example, by selecting a transition temperature below room temperature the device 100 will have superelastic properties. Thus, it will be understood by those of skill in the art that the device 100 may be passed along tortuous paths multiple times without permanent deformation. That is, after being passed along a tortuous path, any deformation of the device 100 may be reversed by returning the device 100 to its memorized shape. For example, after use, the temperature of the device 100 may be lowered below its critical temperature and then raised back above the critical temperature to return the device 100 to its original shape.
  • the superelastic property along with the elastic modulus E of Nitinol also permit the transmission of torque from the proximal end of the device 100 to the distal end 104 thereof to generate usable rotation of the distal end 104 of the longitudinal element 102 via rotation of any other portion of the longitudinal element 102, even while the device 100 extends along a tortuous path.
  • the super elasticity and ease of shape setting may enable improved cutting or biopsy features.
  • the distal portion 108 of the longitudinal element 102 is preferably formed of Nitinol.
  • an entire length of the longitudinal element 102 may also be formed of nitinol.
  • a remaining portion of the longitudinal element may be formed of an alternate material such as, for example, stainless steel.
  • the remaining portion of the longitudinal element 102 may include slots and/or other features formed therein to reduce the bending stiffness of the device 102.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pathology (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Endoscopes (AREA)

Abstract

L'invention porte sur une aiguille destinée à être insérée dans un corps vivant le long d'une voie tortueuse, ladite aiguille comprenant un corps allongé s'étendant entre une extrémité proximale qui, en cours d'utilisation, reste à l'extérieur du corps, et une extrémité distale qui, lorsqu'elle est dans une configuration fonctionnelle, est positionnée à côté d'une structure cible à l'intérieur du corps, une partie distale de l'aiguille comprenant une lumière s'étendant à travers celle-ci jusqu'à une ouverture de réception de tissu au niveau de l'extrémité distale, la lumière ayant un diamètre interne d'au moins 0,035 pouces et une rigidité à la flexion non supérieure à 0,08 Nm2.
PCT/US2011/023598 2010-02-05 2011-02-03 Dispositif de biopsie endoscopique souple guidé par ultrasons WO2011097374A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP2012552082A JP2013518677A (ja) 2010-02-05 2011-02-03 可撓性の内視鏡的超音波ガイド生検デバイス
CA2786908A CA2786908A1 (fr) 2010-02-05 2011-02-03 Dispositif de biopsie endoscopique souple guide par ultrasons
EP11703351A EP2531111A1 (fr) 2010-02-05 2011-02-03 Dispositif de biopsie endoscopique souple guidé par ultrasons

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US30166410P 2010-02-05 2010-02-05
US61/301,664 2010-02-05

Publications (1)

Publication Number Publication Date
WO2011097374A1 true WO2011097374A1 (fr) 2011-08-11

Family

ID=43876990

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2011/023598 WO2011097374A1 (fr) 2010-02-05 2011-02-03 Dispositif de biopsie endoscopique souple guidé par ultrasons

Country Status (5)

Country Link
US (1) US20120035500A1 (fr)
EP (1) EP2531111A1 (fr)
JP (1) JP2013518677A (fr)
CA (1) CA2786908A1 (fr)
WO (1) WO2011097374A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104334162A (zh) * 2012-04-05 2015-02-04 德克萨斯大学系统董事会 多色的pH可激活的荧光纳米平台
US11406363B2 (en) 2016-12-21 2022-08-09 National University Of Ireland Biopsy device

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120245486A1 (en) * 2011-03-25 2012-09-27 Anthony Melchiorri Ghost-core biopsy needle

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997028746A1 (fr) * 1996-02-09 1997-08-14 Emx Guide et methodes d'acces a un site chirurgical ou pharmaceutique
US20040054377A1 (en) * 2002-07-12 2004-03-18 Foster Thomas L. Flexible cannula
DE202005008481U1 (de) * 2005-05-31 2005-08-25 Medi-Globe Gmbh Endkoskopische Punktionsnadelvorrichtung
US20060217681A1 (en) * 2003-01-17 2006-09-28 Applied Medical Resources Corporation Surgical access apparatus and method
WO2007059277A1 (fr) * 2005-11-16 2007-05-24 William Cook Europe Aps Canule

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2590951C (fr) * 2004-12-15 2011-05-17 Wilson-Cook Medical, Inc. Dispositif a aiguille chirurgicale souple

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997028746A1 (fr) * 1996-02-09 1997-08-14 Emx Guide et methodes d'acces a un site chirurgical ou pharmaceutique
US20040054377A1 (en) * 2002-07-12 2004-03-18 Foster Thomas L. Flexible cannula
US20060217681A1 (en) * 2003-01-17 2006-09-28 Applied Medical Resources Corporation Surgical access apparatus and method
DE202005008481U1 (de) * 2005-05-31 2005-08-25 Medi-Globe Gmbh Endkoskopische Punktionsnadelvorrichtung
WO2007059277A1 (fr) * 2005-11-16 2007-05-24 William Cook Europe Aps Canule

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104334162A (zh) * 2012-04-05 2015-02-04 德克萨斯大学系统董事会 多色的pH可激活的荧光纳米平台
US11406363B2 (en) 2016-12-21 2022-08-09 National University Of Ireland Biopsy device

Also Published As

Publication number Publication date
EP2531111A1 (fr) 2012-12-12
CA2786908A1 (fr) 2011-08-11
US20120035500A1 (en) 2012-02-09
JP2013518677A (ja) 2013-05-23

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